Randomized comparison of oesophageal protection with a temperature control device: results of the IMPACT study.

Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology
Lisa W M LeungMark M Gallagher

Abstract

Thermal injury to the oesophagus is an important cause of life-threatening complication after ablation for atrial fibrillation (AF). Thermal protection of the oesophageal lumen by infusing cold liquid reduces thermal injury to a limited extent. We tested the ability of a more powerful method of oesophageal temperature control to reduce the incidence of thermal injury. A single-centre, prospective, double-blinded randomized trial was used to investigate the ability of the ensoETM device to protect the oesophagus from thermal injury. This device was compared in a 1:1 randomization with a control group of standard practice utilizing a single-point temperature probe. In the protected group, the device maintained the luminal temperature at 4°C during radiofrequency (RF) ablation for AF under general anaesthesia. Endoscopic examination was performed at 7 days post-ablation and oesophageal injury was scored. The patient and the endoscopist were blinded to the randomization. We recruited 188 patients, of whom 120 underwent endoscopy. Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 vs. 2/60; P = 0.008), with a trend toward reduction in gastroparesis (6...Continue Reading

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Citations

Mar 3, 2021·Journal of Cardiovascular Electrophysiology·Lisa W M LeungMark M Gallagher
Apr 4, 2021·Journal of Cardiovascular Electrophysiology·James Daniels, Erik Kulstad
May 1, 2021·Journal of Cardiovascular Electrophysiology·Brad Clark, Erik Kulstad
May 1, 2021·Journal of Cardiovascular Electrophysiology·Mahmoud Houmsse, Emile G Daoud
May 25, 2021·HeartRhythm Case Reports·Lisa W M Leung, Mark M Gallagher

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Methods Mentioned

BETA
sedation

Clinical Trials Mentioned

NCT03819946

Software Mentioned

SPSS
GERD

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